Identity
- Trade Name
- THD SLIDE ONE FDA UDI
- Generic Name
- Fibreoptic light cable FDA UDI
- Device Name
- The THD 880018 sterilizable flexible fibre optic cable is to be used in conjunction with the THD Slide disposable kit and the THD disposable diagnostic devices. One end of the cable has a cylindrical anodised aluminium attachment for connection to the light source of the generator (THD Evolution / THD Revolution) and other THD light sources; the other end has a curved stainless steel tip exclusively for THD anoscopes. The cable has an external silicon sheath and an internal reinforcement to prevent damaging the optical fibres. The length of the cable and its extreme flexibility allow the user to easily and comfortably use the instrument. FDA UDI
- Model / Reference
- THD OPTI-FIBER (EVO/BT) FDA UDI
- Description
- The THD 880018 sterilizable flexible fibre optic cable is to be used in conjunction with the THD Slide disposable kit and the THD disposable diagnostic devices. One end of the cable has a cylindrical anodised aluminium attachment for connection to the light source of the generator (THD Evolution / THD Revolution) and other THD light sources; the other end has a curved stainless steel tip exclusively for THD anoscopes. The cable has an external silicon sheath and an internal reinforcement to prevent damaging the optical fibres. The length of the cable and its extreme flexibility allow the user to easily and comfortably use the instrument. FDA UDI
Identifiers
- Catalog Number
- 880018 FDA UDI
- Primary DI / UDI-DI
- 18033737710781 FDA UDI
- 510(k) Number
- K090009 FDA UDI
- FDA Product Code
- JAF FDA UDI
- GMDN Term
- Fibreoptic light cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Fibreoptic light cable
Thd Slide One by Thd Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fibreoptic light cable.
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- JEDMED — JEDMED Instrument Company · Class I
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Cleared under the same submission
K090009 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Thd Spa
Sources (1)
- FDA UDI 19537d1e-d24e-41c5-8495-b373d89f057e 36 fields · synced Jun 1, 2026